Download Moorfields Eye Hospital Collecting a patient specific intraocular lens

Collecting a patient specific
intraocular lens
Clinical Protocol Summary
Outlines the processes for collecting a patient specific intraocular lens power in
adults undergoing cataract surgery
Version:
3.0
Status:
Final
Approved: 12th December 2014 (CAEC chair’s approval)
(CAEC approval 9th January 2015)
Ratified:
12th December 2014
Version History
Version
Date Issued
Brief Summary of
Change
Author
1.0
February 2009
New guideline
A Feeney & Lynn
Marsh
2.0
January 2013
Update guideline
Martin Watson
Melanie Hingorani
Michael Miller
3.0
December 2014
Update guideline
Martin Watson
Melanie Hingorani
Ronald Kam
Vincenzo Maurino
Group responsible for review
and updating of guidelines
Date for review/update of
guidelines
Director of Cataract
Service
December 2017
For more information on
the status of this
document, please contact:
Policy Author
Policy Owner
Department
Accountable Director
Date of issue
Review due
Responsible Committee/
Group for approval
Ratified by
Audience
Martin Watson, Melanie Hingorani
Cataract Service Lead
Cataract
Medical Director and Clinical Director for Surgical
Services
12th December 2014
12th December 2017
Clinical Audit and Effectiveness Committee
Clinical Governance Committee
All clinical staff involved with cataract care
4
Contents
Section
Page
Executive Summary
4
1
Purpose
5
2
Scope
5
3
Explanation of Terms Used
5
4
Guidance
6
5
Duties
8
6
Training
8
7
Stakeholder Engagement and Communication
8
8
Approval and Ratification
8
9
Dissemination and Implementation
8
10
Review and Revision Arrangements
9
11
Document Control and Archiving
9
12
Monitoring compliance with this Policy
9
13
Supporting References / Evidence Base
10
14
Supporting Documents
10
Appendices
Appendix 1
IOL selection sheet
Appendix 2
Patient assessment and treatment record (front cover and
insert)
Appendix 3
Surgical Safety Checklist
Appendix 4
Equality Impact Assessment Tool
Appendix 5
Checklist for the review and approval of Clinical Guidelines
5
1.
Purpose
Cataract extraction is the most commonly performed surgical procedures in the
NHS and the aim of the surgery is to improve vision and to enhance the patient’s
quality of life. An intraocular lens (IOL) is inserted during cataract surgery, after
removal of the natural lens. Implantation of the correct IOL is essential to achieve a
good visual outcome and predicted post-operative refraction.
Selection of the correct power of intraocular lens relies on careful biometry (see
Intra Ocular Lens Measurement Guideline), consideration of all patient specific
factors in selection of the IOL by a clinician (Guidelines for selection of intraocular
lenses in adults) and ensuring the IOL provided to the surgeon is that selected (this
protocol).
The objectives of this protocol are:
 To ensure consistent management throughout the Trust of patients undergoing
cataract surgery
 To ensure all patients attending for cataract surgery will have the correct patient
specific IOL implanted
 To ensure that the maximum number of patients achieve their desired refractive
outcome following surgery
 To reduce unplanned post-operative refractive outcomes
 To prevent ‘Serious Incidents’ (SI) and ‘Never events’
2.
Scope
 This protocol has been developed for all staff involved in the process of
collecting a patient specific IOL to the point of implantation
 This applies to all patients booked for cataract extraction with IOL in one or both
eyes.
 The lens collection procedure can be undertaken by doctors, theatre nurses,
ODA’s (Operating Department Assistants) and support workers (HCA’s).
3.
Explanation of Terms Used
Serious Incidents
‘all events which cause death or serious harm or may impact on an organisation’s
ability to deliver on-going healthcare services’
Never Events
‘a serious, largely preventable patient safety incidents that should not occur if the
available preventative measures have been implemented’
In relation to cataract surgery these include:
 wrong site surgery
 wrong implant/prosthesis
 misidentification of patients
 retained foreign object post-procedure
Insertion of the wrong IOL becomes a ‘Never Event’ if further surgery is required i.e.
IOL exchange, refractive surgery or if there is a complication directly related to the
insertion of the wrong IOL.
6
4.
Procedure
Ward
The admitting doctor must check the biometry data (following Guidelines for
selection of intraocular lens power in adults) and complete the IOL selection sheet
(Appendix 1), signing and dating this in the space provided as ‘IOL selected by:’.
Please note that in some cases, particularly at the satellite sites, the IOL selection
sheet is completed prior to the day of surgery either at the initial consultation or a
few weeks before. Under these circumstances the admitting doctor should carefully
recheck that the IOL selection sheet is completed correctly with the appropriately
selected IOL documented.
Before sending the patient to theatre, the admitting ward staff must complete the
‘Before sending the patient to theatre checklist’ in the Patient assessment and
treatment record (Appendix 2). This includes checking the biometry is in the notes
with the correct patient identification and correct side (left or right eye) and that this
matches the correct side/eye marking and the side/eye on the consent form, and
that the IOL selection sheet has been completed and signed.
Theatre
The theatre staff member receiving the patient into the anaesthetic room will
check the patient (see Reception and checking of the patient into the operating
department 2012).
The IOL power and lens has 2 safety checks (Surgical safety checklist, Appendix 3)
1st Check
As part of the Surgical Safety Checklist, the 1st Check is carried out at the ‘SIGN IN’
by the staff member receiving the patient. This includes checking the IOL
selection sheet is completed and that the IOL is available.
As part of this they must check that:
 Name and hospital number on the biometry, the consent form, the notes and
the IOL selection sheet corresponds to the patient.
 The side/eye marked on the patient matches the side indicated on the
biometry sheet, the IOL selection sheet, the consent form and the theatre list
 The IOL selection sheet is completed with the IOL power written in the box
provided and the lens model ticked or written if another type of lens is
required i.e specific toric IOL
 The IOL selection sheet is signed and dated in the space ‘IOL selected by:’
If a minus lens is to be used then the word ‘minus’ should already be written in the
correct box.
The operating surgeon should also check the biometry data and ‘IOL selection
sheet’ and confirm with a member of theatre staff that the IOL written down should
be the one collected.
Before the patient is anaesthetised, the theatre staff must be certain that the
7
SELECTED IOL IS AVAILABLE. This should then be PHYSICALLY IN
THEATRE WITH THE PATIENT AT THE TIME OUT STAGE.
The ‘SIGN IN’ part of the ‘surgical safety checklist’ is completed to confirm this is
done.
Only one lens at a time is permitted into the theatre.
2nd Check
The 2nd check is at the TIMEOUT on the Surgical safety checklist where the
theatre staff member, scrub nurse and operating surgeon visually and
verbally check that they have the correct patient; that the correct operation is
about to be performed on the correct eye; and that the lens model and power
are correct for that eye.
The check involves three components:
1.
Identity check: details on patient bracelet are read out and confirmed with the
patient (if able to e.g LA) that these are correct. They must match the details on
the front of the notes, consent form, ‘IOL selection sheet’ AND biometry.
Allergies are also confirmed at this stage.
2.
Eye check: the correct eye; ‘Left’ or ‘Right’ for the correct procedure on the
consent form and lens choice written on the correct side of the IOL selection
sheet.
Lens check: the notes must be held up with the IOL selection sheet and biometry
printout visible next to each other simultaneously on facing pages. The power and
model of the handwritten IOL choice on the correct side of the IOL selection
sheet must match the IOL choice for the same eye on the biometry print-out on
the facing page. The IOL box is then opened and a lens sticker is pasted on the
“Paste IOL sticker here during timeout” box on the ‘IOL selection sheet’. The lens
power and model on the sticker must match the handwritten IOL choice
immediately above it on the ‘IOL selection sheet’ and the chosen IOL on the
correct side of the biometry printout on the facing page.
3.
If no discrepancies are identified in the checks above, the lens is then
opened and placed on the scrub nurses trolley.
The TIMEOUT part of the Surgical Safety Checklist is completed to confirm this is
done. This includes ticking the box on the ‘IOL selection sheet’ to confirm that ‘The
surgeon verbally confirms:’
8
At the end of surgery the theatre staff member attaches an implant identification
label onto the patient’s clinical records, theatre lens record and also enters this onto
the computer Galaxy system patient record.
Inserting the correct lens is a team responsibility. It is crucial that, if any
theatre staff members have any concerns as to the consistency of the
paperwork or the correct selection of lens model or power, they must inform
the operating surgeon and the scrub nurse immediately.
It is also important the surgeon respects and supports any team member who
raises a concern and does not continue with implanting the IOL until this has
been resolved.
In the event of the surgeon needing to reassess and recalculate the power of
another lens to the original lens selection, i.e. for vitreous loss, capsule tear, then
the theatre staff member returns the original lens within its packet and opened box
to the theatre coordinator, drawing a line across the previously recorded details
indicating lens return. The unused IOL or IOL packaging must be removed from
theatre before the next patient arrives in theatre. The procedure as set out above is
followed for selection of an alternative lens prior to implantation. On the IOL
selection sheet, the original lens power and model is crossed out and the new lens
power and model written instead. The new lens sticker is either placed over the
original lens sticker or instead of the original lens sticker if this can be removed.
If a lens is faulty or has been opened and not used, these lenses may be returned
to the manufacturer. The lens and packaging are to be saved. Lens sticker to still be
placed on lens record sheet for audit trail
5.
Duties
5.1
Service Directors, the Director of Nursing and Allied Health Professions and
Managers/Nurse Managers/Matrons are responsible for ensuring that this protocol
is distributed and implemented within their areas of responsibility, to ensure that
their staff are aware of the content and its procedures to follow in practice.
5.2
The consultant in charge must ensure adequate supervision of the trainee in
IOL selection and insertion.
5.3
Doctors selecting the IOL and performing cataract surgery must read and
understand this protocol and report any incidents as per the Trust’s Incident
Reporting Policy.
5.4
The ultimate responsibility to insert the correctly planned IOL lies with the
operating surgeon. The surgeon must stop and take action if any member of
staff raises a concern about the correct patient, side or IOL.
5.5
Theatre staff are responsible for ensuring the appropriate paperwork and
checks are completed and that they look for and bring to attention any
possible inaccuracy, discrepancy or mistake to the surgeon as soon as
possible
9
6
6.1
Training
At departmental induction, new members of theatre staff will receive a period of
training and new theatre staff will be assessed against the relevant Trust
Competency according to standard operating procedures. Staff are accountable to
their employer to follow their contract of duty and to their regulatory and
professional bodies. Support workers are accountable to their employer to follow
their contract of employment to undertake tasks delegated to them under the
supervision of a registered practitioner.
7 Stakeholder Engagement and Communication
7.1
7.2
This document has been developed by the Cataract Service and Consultants within
the Cataract Service.
Theatre and satellite managers have also had an opportunity to review this
document.
8 Approval and Ratification
8.1
The guideline has been approved by the Cataract Service meeting, the Cataract
Service Lead and will be approved by the Clinical Audit and Effectiveness
Committee.
8.2
The guidelines will be ratified by the Clinical Governance Committee.
9 Dissemination and Implementation
 To all consultants and medical staff and to all incoming trainees on the service
induction day and general trainee induction.
 Via departmental/service specific Clinical Governance days
 For theatres, the staff will be informed through departmental meetings and the
daily role call meetings in the mornings by the theatre coordinators when there
are changes to the protocols and competencies.
 To all ward managers
 This guideline is available on the intranet and also circulated to all managers
and theatre sister.
 Communication via Chief Executives newsletter to all staff
10 Review and Revision Arrangements
10.1 The guideline will be reviewed by the Policy Owner/Author every three years or
earlier if required due to further Never Events or changes in technology or Royal
College Guidance.
11 Document Control and Archiving
11.1 The current and approved version of this document can be found on the Trust’s
intranet site. Should this not be the case, please contact the Head of Clinical
Governance.
11.2
Previously approved versions of this document will be removed from the intranet by
the Head of Clinical Governance and archived. Any requests for retrieval of
archived documents must be directed to the Head of Clinical Governance or Risk
and Safety team.
12 Monitoring compliance with this Policy
10
12.1
The Trust will use a variety of methods to monitor compliance with the processes in
this document, including the following methods:
Measurable
Policy
Objective
Monitoring/ Audit
method
Frequency
of
monitoring
Responsibility
for
performing
the
monitoring
Adherence to
processes in
policy
Audit using
undercover live
monitoring of the
protocol in theatres
At the
discretion
of the
Cataract
Service
Director
Audit of
compliance is
expected
among all
consultants
and trainees
under their
supervision in
clinics and
theatres.
Audit of randomly
selected notes for
evidence of
completion of the
Surgical safety
checklist and IOL
selection sheet
Monitoring
reported to
which
groups/
committees,
inc
responsibility
for reviewing
action plans
Management
Executive
Head of
Clinical
Governance
Serious Incidents and
Never events
reporting
Cataract
Service
Director
IOL exchange
procedures derived
from theatre
computer
management system
In addition to the monitoring arrangements described above the Trust may
undertake additional monitoring of this policy as a response to the identification of
any gaps, or as a result of the identification of risks arising from the policy prompted
by incident review, external reviews or other sources of information and advice.
This monitoring may include commissioned audits and reviews, detailed data
analysis or another focussed study, for example. Results of this monitoring will be
reported to the committee and/or individual responsible for the review of the
process and/or the risks identified.
Monitoring at any point may trigger a policy review if there is evidence that the
policy is unable to meet its stated objectives.
13 Supporting References / Evidence Base
 Jackson T (2008) Moorfields Manual of Ophthalmology .China :Elsevier
 Morrin J (2005) Working Protocol for the selection and collection of intraocular
lens requested in theatre Moorfields Eye Hospital NHS Foundation Trust.
 National patient safety Agency (NPSA) (2005) Safer Patient Identification.
11




National patient safety Agency (NPSA) (2005) Correct Site Surgery.
HSC 2001/023 Good Practice in consent
The Royal College of Ophthalmologists 2012/EACT/002 - external review from
the Royal College of Ophthalmologists following ‘Never Events’ at the Moorfields
NHS Trust.
Guidelines for selection of intraocular lens power in adults – Local guidelines,
updated October 2012
14 Supporting Documents


IOL Measurement (Adult) Guideline
Guidelines for selection of IOL in adults
12
Appendix 1
13
Appendix 2
14
Appendix 3
Appendix 4
Equality Impact Assessment
The equality impact assessment is used to ensure we do not inadvertently discriminate as
a service provider or as an employer.
To be completed and attached to any procedural document when submitted to the
appropriate committee for consideration and approval.
Yes/No
Comments
1. Does the policy/guidance affect one
group less or more favourably than
another on the basis of:

Race
No

Ethnic origins (including gypsies
and travellers)
No

Nationality
No

Gender
No

Gender reassignment
No

Culture
No

Pregnancy and maternity
No

Marriage and civil partnership
No

Religion or belief
No

Sexual orientation including
lesbian, gay and bisexual people
No

Age
No

Disability (e.g. physical, sensory or
learning)
No

Mental health
No
2. Is there any evidence that some
groups are affected differently?
No
3. If you have identified potential
discrimination, are any exceptions
valid, legal and/or justifiable?
N/A
4. Is the impact of the policy/guidance
likely to be negative?
No
5. If so can the impact be avoided?
N/A
6. What alternatives are there to
achieving the policy/guidance without
the impact?
N/A
7. Can the impact be reduced by taking
N/A
different action?
If you have identified a potential discriminatory impact of this procedural document, please
refer it to the director of corporate governance, or the human resources department,
together with any suggestions as to the action required to avoid/reduce this impact.
Appendix 4
For advice in respect of answering the above questions, please contact the director of
corporate governance (ext. 2306)
Please ensure that the completed EIA is appended to the final version of the document, so
that it is available for consultation when the document is being approved and ratified, and
subsequently published.
Appendix 5
Checklist for the Review and Approval of Clinical Guidelines
To be completed (electronically) and attached to any document which guides practice
when submitted to the appropriate committee for approval or ratification.
Title of the document:
Policy (document) Author:
Policy (document) Owner:
Yes/No/
Unsure/
NA
1.
2.
3.
Title
Is the title clear and unambiguous?
Yes
Is it clear that this document is a
Clinical Guideline?
Yes
Scope/Purpose
Is the target population clear and
unambiguous?
Yes
Is the purpose of the document clear?
Yes
Are the intended outcomes described?
Yes
Are the statements clear and
unambiguous?
Yes
Development Process
Is there evidence of engagement with
stakeholders and users?
4.
5.
Yes
Who was engaged in a review of the
document (list committees/
individuals)?
Yes
Has the policy template been followed
(i.e. is the format correct)?
Yes
Evidence Base
Is the type of evidence to support the
document identified explicitly?
Yes
Are local/organisational supporting
documents referenced?
Yes
Approval
Does the document identify which
committee/group will approve/ratify it?
Yes
Comments
Appendix 5
Yes/No/
Unsure/
NA
If appropriate, have the joint human
resources/staff side committee (or
equivalent) approved the document?
6.
7.
Is there an outline/plan to identify how
this will be done?
Yes
Does the plan include the necessary
training/support to ensure compliance?
Yes
Process for Monitoring Compliance
Yes
Overall Responsibility for the
Document
Is it clear who will be responsible for
coordinating the dissemination,
implementation and review of the
documentation?
10.
Yes
Review Date
Is the review date identified and is this
acceptable?
9.
Yes
Dissemination and Implementation
Are there measurable standards or
KPIs to support monitoring compliance
of the document?
8.
Comments
Yes
Equality Impact Assessment (EIA)
Has a suitable EIA been completed?
Yes
Committee Approval (Clinical Audit and Effectiveness Committee)
If the committee is happy to approve this document, please complete the section below, date it
and return it to the Policy (document) Owner
Name of
Chair
Melanie Hingorani
Date
12th
December
2014
(Chair’s
approval at CGC, CAEC approval
January 2015)
Ratification by Management Executive (if appropriate)
If the Management Executive is happy to ratify this document, please complete the date of
ratification below and advise the Policy (document) Owner
Date: